Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival
Corewell Health East
Summary
This is a prospective, parallel, non-blinded, two-arm randomized controlled trial of intravenous catheter failure evaluating the impact of a built-in guide wire. The objective of this study is to demonstrate that the control ultralong intravenous catheter (IV) without the guide wire is non-inferior to the experimental catheter with the guide wire. After obtaining consent, eligible patients will be randomly allocated to control Arm 1 (ultralong intravenous catheter) or experimental Arm 2 (ultralong intravenous catheter with guide wire) in a ratio of 1:1 via a computer-generated randomization schedule. The participants will be followed to collect data until the catheter is removed.
Description
This is a prospective, parallel, non-blinded, two-arm randomized (like the flip of a coin) controlled trial of catheter failure evaluating the impact of a built-in guide wire. This study plans to enroll 360 participants (two equally sized groups of 180 participants in each arm). Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. After study participant enrollment, the clinician participant is engaged to perform the procedure. Randomization will occur and placement…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Study Participants Inclusion Criteria: ≥ than 18 years old Vascular Access Score of 4 or 5 Vascular Access Score: 1. Visible with distention and easily palpable 2. Visible and easily palpable 3. Not visible and easily palpable 4. Visible and poorly palpable 5. Not visible and poorly or non-palpable Study participants exclusion criteria: \<18 years old Restricted mobility of elbow joint Cognitively impaired. Skin complications that limit access to the potential IV site Clinician Participants Inclusion Criteria: Clinician working in the emergency department at Corewell Health William Beau…
Interventions
- DeviceB. Braun 6.35cm 20 gauge ultralong intravenous catheter
B Braun Medical Inc, 6.35cm 20 gauge ultralong intravenous catheter
- DeviceBD 5.71 cm 20 gauge Accucath
Bard Access Systems, Inc, BD 5.71 cm 20 gauge ultralong intravenous catheter with guide wire
Location
- Beaumont Hospital - Royal OakRoyal Oak, Michigan